Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00032825 · ClinicalTrials.gov registry record · Phase 1
Ketoconazole Plus Docetaxel to Treat Prostate Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 674
- Enrollment target
NCT00032825: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00032825 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 674 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1023% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00032825, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 674 participants
- Enrollment target
Study Summary
This study will determine the maximum dose of docetaxel that can be given safely in combination with ketoconazole for treating advanced prostate cancer. Docetaxel is approved for the treatment of several other types of cancers; ketoconazole is an approved antifungal medication that is also commonly used in high doses to treat prostate cancer. Patients 18 years of age and older with advanced prostate cancer that does not respond to hormone therapy may be eligible for this study. Candidates will be screened with blood tests to evaluate liver, kidney and other organ function and with x-rays, scans, or other imaging tests to determine the extent of disease. Participants will take the following medications: * Docetaxel daily, infused through a vein over 30 minutes, in 4-week cycles-3 consecutive weeks of drug followed by one week of rest * Dexamethasone, 12 hours and 1 hour before and 12 hours after docetaxel infusions to help prevent fluid retention caused by the docetaxel * Ketoconazole, 3 times a day * Hydrocortisone, twice a day to replace a loss of natural steroids caused by the ketoconazole Patients will be hospitalized 1 to 2 days each for the first and second doses of docetaxel to allow for frequent blood draws to measure blood levels of the drug. Ketoconazole will be started about 2 weeks after the first dose of docetaxel and the second dose of docetaxel will be given 2 days after that. In order to determine the maximum tolerated dose of docetaxel, the first few patients in the study will be given a low dose of the drug, and subsequent patients will get increasingly higher doses until unacceptable side effects occur. Because prostate cancer cells may grow if exposed to testosterone, patients may have to have their testosterone production suppressed either surgically (removal of the testicles) or medically with an injection of leuprolide or goserelin, which are luteinizing hormone-release hormone agonists that reduce the amount of testosterone. Imaging studi
Interventions
- DRUG Docetaxel
- DRUG Ketaconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 674 participants |
| Start Date | 2002-03-19 |
| Est. Completion | 2011-06-13 |
| Phase | Phase 1 |
What the finished NCT00032825 record still lists
NCT00032825 is an interventional study that assigns participants to a tested intervention. The registered 674 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1023% higher).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT00032825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00032825 about?
NCT00032825 is a clinical study titled "Ketoconazole Plus Docetaxel to Treat Prostate Cancer". This study will determine the maximum dose of docetaxel that can be given safely in combination with ketoconazole for treating advanced prostate cancer. Docetaxel is approved for the treatment of several other types of cancers; ketoconazole is an approved antifungal medication that is also commonly ...
What is the current status of trial NCT00032825?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 674 participants. The study started on 2002-03-19. Estimated completion is 2011-06-13.
What interventions are being tested in trial NCT00032825?
The interventions under investigation include: Docetaxel (DRUG), Ketaconazole (DRUG).
Who is sponsoring clinical trial NCT00032825?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00032825's enrollment target sits among peer trials
674 22nd of 2000 higher than 1,979 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06335381 · 674 participants · NA
MOMs Chat and Care Study
- NCT06757634 · 674 participants · Phase 3
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
- NCT04788277 · 675 participants
Investigation Into Detection of Prostate Cancer Using Voided Urine (Prostate VPAC)
- NCT05356234 · 675 participants · NA
Ignite Study of the Jewish Family and Children's Service of the Suncoast, Inc.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI